Attention deficit hyperactivity disorder (ADHD) is a common childhood behavior disorder that causes impaired functioning in multiple settings, including home, school, and in relationships with peers. Symptoms of ADHD include impulsiveness, hyperactivity, and inattention. Both medications and behavior therapies have been shown to be effective in treating ADHD. It is essential, however, that children take their medication regularly for it to be effective. This three-phase study will develop and test a provider-administered intervention to improve medication adherence and persistence among children with ADHD and their caregivers.

The first phase of this study will gather information about perspectives on ADHD and its treatment by using focus groups and interviews with participating children and their parents. Phase two of the study will gather information on medication adherence and persistence, as well as demographic information. Phase three of the study will involve developing and testing a three part intervention consisting of an ADHD education component, a short survey to help parents identify non-adherence warning signs, and tailored medication messages for parents. After conducting a pilot with five parent-child pairs to assess feasibility and accessibility, all interested doctors at the study site will receive a lecture on evidence-based treatments for ADHD and a supply of parent ADHD education toolkits. Half of the doctors will be randomly assigned to receive additional training on the experimental procedures and to administer the intervention as part of the study. Parent and child participants will be randomly assigned to receive either treatment with a doctor who has been trained on the experimental intervention or treatment as usual. Assessments will take place at the beginning of treatment and 1, 3, and 6 months after the start of treatment. During each assessment, a saliva sample will be collected from the child, and parents will complete several checklists and questionnaires about ADHD treatment and medication adherence.

Eligibility

Ages Eligible for Study:

6 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

PHASE I:

Inclusion Criteria:

Parent Focus Group Participants:

Must be primary caregiver and legal guardian of child (6-10 years) at time of initial ADHD diagnosis

Child must have been diagnosed with ADHD within the last 18 months at Schneider Children's Hospital's (SCH) outpatient clinic (co-morbid diagnosis of oppositional defiant disorder [ODD] or conduct disorder [CD] is permitted)

Child has significant co-morbid medical conditions, such as diabetes, cystic fibrosis, or severe asthma, resulting in more than 2 emergency visits in the last year

Child has a co-morbid diagnosis of psychosis, bipolar disorder, or other serious psychiatric condition within 12 months prior to study entry

Child has history of psychiatric hospitalization within 12 months prior to study entry

Child is receiving treatment in a different setting

PHASE II:

Inclusion Criteria:

Primary caregiver and legal guardian of child (6-10 years) at the time of initial ADHD diagnosis

Child has been diagnosed with ADHD within the last 18 months at SCH's outpatient clinic

Exclusion Criteria:

Parents of children with co-morbid medical conditions other than oppositional defiant disorder (ODD) or conduct disorder (CD)

Parents of children with a co-morbid diagnosis of psychosis, bipolar disorder, mental retardation, or other severe mental illness, evidence of mental retardation, or history of psychiatric hospitalization within 12 months prior to study entry

Child is receiving treatment in a different setting

PHASE III:

Inclusion Criteria:

Medication naïve children with a primary diagnosis of ADHD (co-morbid ODD will be permitted) at the Child Psychiatric Outpatient Department at SCH

Parents are the legal guardians

Both parents and children willing to sign the informed consent/assent

Exclusion Criteria:

Children with co-morbid medical conditions other than ODD

Children with a co-morbid diagnosis of psychosis, bipolar disorder, or other serious psychiatric condition, evidence of mental retardation, or history of recent hospitalization

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429221